Tissue manipulation is often required for the completion of certain medical procedures. It may be advantageous or necessary for example to remove a sample of tissue from a patient if it is determined to be diseased or suspected of being diseased. Such tissue manipulation may be a component of biopsy procedures like those used to determine whether tissue is cancerous.
Bladder cancer, for example, affects a great number of individuals throughout the world. Intravesical imaging and localized or site specific treatments are a standard of care for patients whose disease is in the early stages. Many lesions are difficult to reliably access and appropriately sample using current techniques. This is especially true of lesions located on the bladder dome, anterior bladder wall, or immediately adjacent to the bladder outlet. These clinical realities lead to less effective diagnosis and treatment for some lesions. Virtually all of these procedures, as well as similar procedures done on other organs such as the esophagus, are typically image guided by use of an endoscope.
Endoscopes have origins that date back to the early 1800s. Human medical use began to be a routine function of the endoscope beginning in the early 1900s with the introduction of laparoscopy. Virtually all improvements and modifications of endoscopes have been based on the desire for better and larger images from smaller and smaller devices.
Endoscopic surgery also dates to the early 1900s. It was drastically improved in 1970s when computer chip cameras were incorporated into endoscopes and its utility greatly expanded. See, for example, Clarke, H. C., Laparoscopy: New Instruments for Suturing and Ligation: Fertil. Steril. 23, 274 (1972). The endoscope has remained primarily an optical imaging system for the visual guidance of additional tools.
Current management of localized bladder cancer utilizes transurethral resection of balder tumor (TURBT) procedure in order to both treat and stage this malignancy. This procedure is typically performed using rigid (non-flexible) instrumentation and employs electrocautery for tissue procurement. Patients whose tumors do not invade the detrussor muscle of the bladder (such as Ta or T1 tumors), generally undergo intravesical chemotherapy and/or immunotherapy and close cystoscopic surveillance. Patients with early stage cancers are scoped approximately every 3 to 6 months. Recurrences are common.
Staging of bladder cancer with transurethral resection is currently the standard of care; however, staging inaccuracies are well-documented and present great clinical concern. In some studies, greater than 25% of patients with recurrent T1 disease (invasion into the bladder lamina propria but not into muscle) who undergo cystectomy are found to have been understaged with TURBT. Suboptimal sampling of the detrussor muscle and cautery artifact inherent to the procedure often results in missed diagnoses of T2 disease. These in turn stem from inherent limitations of modern transurethral instrumentation and from routine use of electrocautery to procure pathological tissue specimens. Understaging of T1 bladder urothelial carcinoma is underscored by a very troubling cancer-specific mortality rate of as high as 30%.
While various tissue manipulation systems and methods have been proposed, there remains a need for improved systems and methods for manipulating target tissue of a patient during a medical procedure such as a bladder biopsy. Improved safe and accurate staging of bladder cancer represents a goal with enormous clinical and scientific merit.